# K140208: Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem, and Fem-Flexii

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Mar 5, 2014 after 36 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 7 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K891576 (1989). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123298: Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo Coating, Edwards Lifesciences, LLC (2013) Summary page 1.
- K123303: Femoral Access Venous Cannulae, Edwards Lifesciences, LLC (2013) Summary page 1.

## Most influential descendants
- K200358: Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula (2020), 0 descendants of its own

## Recalls of this device
- May 14, 2025 · Class I · Z-2082-2025: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- May 14, 2025 · Class I · Z-2085-2025: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- May 14, 2025 · Class I · Z-2084-2025: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- May 14, 2025 · Class I · Z-2083-2025: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- Mar 7, 2018 · Class II · Z-3032-2018: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- Mar 7, 2018 · Class II · Z-3033-2018: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- Mar 23, 2015 · Class II · Z-1371-2015: Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral Arterial Cannula sizes 8, 10, 12 French because of the potential of tissue damage caused by a protruding wire located at the tip of the 

## Indications for use
Edwards Litesciences Femoral Access Cannulae are intended for use in situations which require rapid femoral venious and arterial access for short-term (:5 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Femoral access cannulae may be used in pediatric populations or aduht populations based on flow rate requirements and Individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

Source page: https://510kreport.com/device/K140208
Methodology: https://510kreport.com/methodology